FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen...
Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer
A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...
Does Tailored Lifestyle Feedback Given During Colorectal Cancer Screening Improve Disease-Preventive Behaviors?
A program that provided individually tailored lifestyle recommendations for patients undergoing screening for colorectal cancer helped encourage healthy behavior, according to results published by Knudsen et al in Cancer Epidemiology, Biomarkers & Prevention. “It is well known that...
Regorafenib in Previously Treated Metastatic Osteosarcoma
In a phase II trial reported in The Lancet Oncology, Duffaud et al found evidence of activity of regorafenib (Stivarga) in a cohort of adult patients with previously treated metastatic osteosarcoma. This noncomparative, double-blind trial involves 4 cohorts of patients, consisting of those with...
Apixaban Thromboprophylaxis in Patients With Cancer
In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...
Aggressive Squamous Cell Carcinoma in Solid Organ Transplant Recipients
Squamous cell carcinoma (SCC) is the most frequently diagnosed cancer in recipients of a solid organ transplant. When organ transplant recipients are diagnosed with SCC, they are also at higher risk for a more aggressive disease course, metastasis, and death than the general population. Researchers ...
CIMRA Assay for Detection of Gene Variants in Lynch Syndrome
An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...
Addition of Veliparib to Cisplatin/Etoposide in Extensive-Stage SCLC
In the phase II ECOG-ACRIN 2511 trial reported in the Journal of Clinical Oncology, Owonikoko et al found that the addition of the poly (ADP ribose) polymerase (PARP) inhibitor veliparib to cisplatin/etoposide was associated with a modest but statistically significant improvement in...
Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3
An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...
ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma
As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...
RSNA 2018: Mammography Screening Beyond Age 75
Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....
RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women
A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...
RSNA 2018: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers
Cryoablation has shown early indications of effectiveness in treating women with low-risk breast cancers, according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSM01-01). “If the positive preliminary findings are maintained as the ...
SELECT Trial: Adjuvant Erlotinib in Resected EGFR-Mutant NSCLC
In a phase II trial reported in the Journal of Clinical Oncology, Pennell et al found that adjuvant erlotinib (Tarceva) improved disease-free survival over historical controls in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). In the study, 100 patients with ...
Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy
In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...
Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas
In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...
Vitamin D Supplementation and Cancer Risk
In a trial reported in The New England Journal of Medicine by Manson et al, vitamin D supplementation was found to have no benefit in reducing risk of invasive cancer vs placebo over 5 years of follow-up. Study Details The trial was a randomized, placebo-controlled trial, with a two-by-two...
Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer and Misdiagnosis of MSI or dMMR Status
In a study reported in JAMA Oncology, Cohen et al found evidence that primary resistance to immune checkpoint inhibitor treatment in metastatic colorectal cancer (CRC) can be explained in some cases by misdiagnosis of microsatellite instability (MSI) or defective mismatch repair (dMMR) status....
POEMS/SWOG Intergroup S0230 Study on Preventing Early Menopause
In the long-term follow-up of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the National Cancer Institute, Moore et al found that the addition of goserelin (Zoladex) to cyclophosphamide-containing chemotherapy was associated with a higher...
ASCO and Friends of Cancer Research Applaud NCI’s Expansion of Clinical Trial Eligibility Criteria
ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute's (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
SABCS 2018: Oxybutynin for the Management of Hot Flashes in Women Unable to Receive Hormone Replacement Treatment
Treatment with oxybutynin helped reduce the frequency and intensity of hot flashes for women who could not take hormone replacement therapy, including breast cancer survivors, according to the results of a trial presented at the 2018 San Antonio Breast Cancer Symposium by Leon-Ferre et al (Abstract ...
SABCS 2018: SOLAR-1: Liquid Biopsies in Predicting Benefit of Alpelisib in PIK3CA-Mutant Breast Cancer
Liquid biopsy–based assessment of PIK3CA mutational status served as a better indicator of progression-free survival compared with analysis of tissue biopsy in patients with breast cancer enrolled in the phase III SOLAR-1 clinical trial, according to data presented by Juric et al at the 2018...
SABCS 2018: TAILORx Results Show Association Between Clinical Outcomes in Breast Cancer and Race
An analysis of the association between clinical outcomes and race in participants enrolled in the TAILORx trial found that even with equivalent treatments among women with hormone receptor–positive, HER2-negative breast cancer, black women had worse clinical outcomes than white women, despite ...
FDA Approves Atezolizumab in Combination With Bevacizumab and Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC
On December 6, 2018, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or...
SABCS 2018: Surgical Choice May Impact Long-Term Quality of Life in Young Adults With Breast Cancer
A study by Dominici et al investigated the long-term quality of life outcomes in young breast cancer survivors across three surgical strategies: breast-conserving surgery, unilateral mastectomy, and bilateral mastectomy. The researchers found that patients who underwent mastectomy had lower breast...
SABCS 2018: Whole-Breast Irradiation vs Accelerated Partial-Breast Irradiation for Preventing Ipsilateral Breast Tumor Recurrence
Data from the NSABP B-39/RTOG 0413 trial indicated that ipsilateral breast tumor recurrence (IBTR) rates 10 years after treatment could not reject the hypothesis that accelerated partial-breast irradiation (PBI) after lumpectomy was inferior to whole-breast irradiation (WBI), according to a...
SABCS 2018: Low-Dose Tamoxifen in Reducing Recurrence and New Disease for Patients With Breast Intraepithelial Neoplasia
Treatment with a low dose of tamoxifen (5 mg/d), compared with placebo, decreased the risk of disease recurrence and new disease for women who had been treated with surgery following a diagnosis of breast intraepithelial neoplasia. Moreover, it did not cause more serious adverse events, according...
SABCS 2018: AMAROS Trial: 10-Year Follow-up of Axillary Radiotherapy or Surgery in Early-Stage Breast Cancer
Patients with early-stage breast cancer who had cancer detected in a sentinel lymph node biopsy had comparable 10-year recurrence and survival rates following either axillary radiotherapy or axillary lymph node dissection, according to data from the randomized, phase III AMAROS clinical trial...
SABCS 2018: Circulating Tumor Cell Count May Help Choose First-Line Treatment for Metastatic Breast Cancer
A phase III study by Bidard et al investigated whether circulating tumor cells could help physicians choose between hormone therapy or chemotherapy as front-line therapy for patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer. The researchers concluded that the...
SABCS 2018: Meta-analysis of Pathologic Complete Response and Outcomes in Breast Cancer
Pathologic complete response after neoadjuvant chemotherapy was associated with a significantly lower recurrence risk and higher overall survival in patients with breast cancer, and pathologic complete response after neoadjuvant chemotherapy had a similar association with improved outcomes...
SABCS 2018: Delayed Initiation of Adjuvant Chemotherapy Associated With Worse Outcomes in Patients With Triple-Negative Breast Cancer
A retrospective study evaluating the influence of time to chemotherapy on patients with triple-negative disease and its impact on survival outcome has found that patients who delayed adjuvant chemotherapy more than 30 days after surgery had a significantly higher risk for disease recurrence and...
ASH 2018: Researchers Identify Mutation in BCL2 Protein That Causes Resistance to Venetoclax in Progressive CLL
Investigators from Australia have identified a genetic mutation that causes resistance to the targeted drug venetoclax (Venclexta) in patients with chronic lymphocytic leukemia (CLL), according to research presented by Blombery et al at the 2018 American Society of Hematology (ASH) Annual Meeting...
ASH 2018: Ibrutinib Plus Rituximab vs Standard Chemoimmunotherapy in Younger Patients With Treatment-Naive CLL
A 6-month course of chemotherapy-based treatment with FCR (intravenous fludarabine and cyclophosphamide plus rituximab [Rituxan]) has historically been the most effective treatment for chronic lymphocytic leukemia (CLL), especially in patients 70 years of age and younger. However, results from a...
SABCS 2018: Does Adjuvant Capecitabine Improve Outcomes in Early-Stage Triple-Negative Breast Cancer?
Treating patients with early-stage triple-negative breast cancer with capecitabine after surgery and standard chemotherapy did not significantly improve disease-free or overall survival compared with observation, according to data from the randomized, phase III GEICAM/CIBOMA clinical trial...
SABCS 2018: KATHERINE Trial: Adjuvant Ado-Trastuzumab Emtansine vs Trastuzumab in Early-Stage HER2-Positive Breast Cancer
The phase III KATHERINE clinical trial compared the use of ado-trastuzumab emtansine (T-DM1; Kadcyla) vs trastuzumab (Herceptin) as adjuvant therapy in patients with HER2-positive early-stage breast cancer with residual invasive disease after receiving neoadjuvant chemotherapy and...
ASH 2018: MAIA Trial: Does Adding Daratumumab Improve Outcomes in Patients With Newly Diagnosed Multiple Myeloma Ineligible for Stem Cell Transplant?
Interim results from a large international phase III clinical trial show that adding the immunotherapy daratumumab (Darzalex) to standard therapy significantly extended progression-free survival (PFS) in newly diagnosed patients with multiple myeloma who were ineligible for a stem cell transplant....
ASH 2018: CASSINI Trial: Rivaroxaban Thromboprophylaxis for VTE Prevention in Patients With Cancer
A new study suggests taking a direct oral anticoagulant (DOAC) can reduce the risk of harmful blood clots in patients undergoing cancer treatments, without substantially increasing the risk of bleeding problems. Findings from the CASSINI trial were presented by Khorana et al at the 2018 American...
Survival With Surgery vs Radiotherapy in Gleason Score 9–10 Prostate Cancer
In a cohort study reported in JAMA Oncology, Tilki et al found that patients with Gleason score 9–10 prostate cancer treated with multimodality therapy known as MaxRP (radical prostatectomy [RP] plus adjuvant external-beam radiotherapy [EBRT] with or without androgen-deprivation therapy...
Factors Affecting Use of Outpatient Specialty Palliative Care Clinics Among Patients With Advanced Cancer
In a study reported in the Journal of Oncology Practice, Yu et al identified factors affecting use of outpatient specialty palliative care (OSPC) among patients with advanced cancer in the University of Pittsburgh Medical Center Hillman Cancer Center Network (UPMC-HCCN). Study Details The...
ASH 2018: CAR.CD30 T-Cell Therapy in Relapsed or Refractory CD30-Positive Lymphomas
At the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, Grover et al presented preliminary results from a clinical study of an investigational cellular immunotherapy for Hodgkin lymphoma and non-Hodgkin lymphoma expressing the CD30 protein marker (Abstract 681). Data...
ASH 2018: Apixaban for the Treatment of Cancer-Associated VTE
According to findings from the ADAM VTE trial, an oral drug, apixaban (Eliquis), is safe and effective in treating blood clots in patients undergoing cancer therapy. The drug was associated with fewer major bleeding events and fewer recurrent blood clots compared to low–molecular-weight. ...
Marine Omega-3 Fatty Acid Supplementation and Cancer Risk
In a trial reported in The New England Journal of Medicine by Manson et al, marine n-3 (omega-3) fatty acid supplementation was found to have no benefit in reducing the risk for invasive cancer vs placebo over 5 years of follow-up. Higher intake of n-3 fatty acids has been associated with a reduced ...
ASH 2018: Update of ZUMA-1: Axicabtagene Ciloleucel in DLBCL
A follow-up analysis of patients enrolled in the multicenter ZUMA-1 trial for diffuse large B-cell lymphoma (DLBCL) showed axicabtagene ciloleucel can induce durable responses, yield a median overall survival of more than 2 years, and has a manageable long-term safety profile. Axicabtagene...
ASH 2018: Machine Learning–Based Model to Risk Stratify Patients With Myelodysplastic Syndromes
Researchers used machine learning to develop a new system to analyze genomic and clinical data to provide a personalized overall outcome that is patient-specific in myelodysplastic syndromes. In tests, the system outperformed the current standard prognostic tool, suggesting the new model may offer...
ASH 2018: Rapid Genetic Screening Shows Feasibility of Precision Medicine for AML
A new study demonstrated it is feasible for health-care providers to determine which molecular subtype of acute myeloid leukemia (AML) a patient has before beginning treatment and to use this information to pick an approach that best matches the individual. The results, presented by Burd et al at...
ASH 2018: Hematopoietic Stem Cell Transplant After CD19 CAR T-Cell Therapy in ALL
In a new study presented by Summers et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 967), patients with acute lymphoblastic leukemia (ALL) who received a first stem cell transplant after CD19 chimeric antigen receptor (CAR) T-cell therapy were less...
ASH 2018: Checkpoint Inhibitors Plus CAR T-Cell Therapy in Relapsed ALL
CD19-directed chimeric antigen receptor (CAR) T-cell therapy has been shown to be effective in patients with relapsed B-cell acute lymphocytic leukemia (B-ALL). However, in some patients, the antitumor effects of CAR T-cell treatment are short-lived, which may, in part, be caused by a reaction of...
ASH 2018: MEDALIST: Luspatercept in Patients With Myelodysplastic Syndrome Requiring Red Blood Cell Transfusion
In the phase III MEDALIST clinical trial, luspatercept significantly reduced the need for frequent blood transfusions in just over half (53%) of patients with myelodysplastic syndromes (MDS) who were anemic, required regular red blood cell transfusions, and showed abnormal iron overload in red...
